Recruiting

Mindfulness

Sponsor:

University of British Columbia

Code:

NCT05939492

Conditions

Chest Pain

Eligibility Criteria

Sex: All

Age: 11 - 18

Healthy Volunteers: Not accepted

Interventions

Mindfulness-Based Intervention

Study Details

Brief summary:

The goal of this clinical trial is to test mindfulness practices in children with idiopathic chest pain, which is chest pain that does not have a known cause. The main question this study aims to answer is whether children who experience idiopathic chest pain are able to follow a mindfulness program. This study also aims to determine whether mindfulness affects the way children with idiopathic chest pain cope, and if it affects their stress levels, quality of life, frequency of chest pain episodes, and chest pain intensity.

Participants will:

  • Complete a survey at the beginning of the study that asks questions about their sex, ethnicity, and history of chest pain and other chronic pains.
  • Complete a short survey every day for the entirety of the study that asks about the number, intensity, and duration of chest pain episodes experienced that day.
  • Complete 4 surveys, 2 weeks after they have been enrolled in the study: pain coping survey, perceived stress survey, quality of life survey, and mindfulness survey.
  • Be randomly placed into either the control group or the mindfulness-based intervention group, 2 weeks after they have been enrolled in the study.
  • Receive the standard of care for children with idiopathic chest pain, if they are placed into the control group.
  • Use the mobile app Headspace to complete daily mindfulness sessions for the remaining 30 days of the study (starting after the initial 2 week period), if they are placed in the mindfulness-based intervention group.
  • Complete 4 surveys at the end of the study: pain coping survey, perceived stress survey, quality of life survey, and mindfulness survey.
  • Complete a mindfulness program evaluation survey at the end of the study, only if they are in the mindfulness-based intervention group.

Researchers will collect information from Headspace to see how well participants in the mindfulness-based intervention group are able to follow the mindfulness program. This will help guide future, larger studies that look at the effects of mindfulness-based interventions in children with idiopathic chest pain. Researchers will also compare survey results between the control group and the mindfulness-based intervention group to see if the mindfulness program affects the way children with idiopathic chest pain cope, as well as their stress levels, quality of life, frequency of chest pain episodes, and chest pain intensity.

Conditions

Chest Pain

Study ID

NCT05939492

Start date

Mar 25, 2024

Status verified date

May, 2024

Completion date

Mar, 2025

Anticipated

Primary completion date

Mar, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 11 - 18

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patients whose primary complaint is recurrent chest pain that is diagnosed as idiopathic or musculoskeletal by a pediatric cardiologist.
  • No acute illness.
  • Normal ECG.
  • Willing and able to download and use the Headspace application on a daily basis.
  • Able to complete surveys in the English language.

Exclusion Criteria:

  • Patients whose chest pain is secondary to pericarditis, arrhythmia, or structural heart disease.
  • Patients with concurrent symptoms that could potentially interfere with the ability to determine the effect on their chest pain (e.g., palpitations or dizziness).
  • Unable to provide informed assent.

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

no intervention: Standard of Care Control

Participants in this arm will receive the standard of care. For patients with idiopathic chest pain, the standard of care is typically just reassurance of the benign nature of their pain.

experimental: Mindfulness-Based Intervention

Participants in this arm will partake in a 30 day mindfulness-based intervention on the mobile app Headspace.

Interventions

Mindfulness-Based Intervention

Participants in the mindfulness-based intervention (MBI) group will be asked to use the Headspace app to sequentially complete the "Basics", "Basics 2", and "Basics 3" courses. Each of these courses lasts 10 days, and participants have the ability to choose how long daily sessions last. Participants can choose between 3, 5, or 10-minute sessions for the "Basics" course; 10 or 15-minute sessions for the "Basics 2" course; and 10, 15, or 20-minute sessions for the "Basics 3" course. These daily sessions are audio recordings that prompt users to engage in a variety of mindfulness techniques, including focusing on their body and breathing, as well as acknowledging thoughts and emotions in a non-judgmental manner.

Primary outcome measure

  • Feasibility: Participant Recruitment Rate [ Time Frame: Baseline (0 days) ]
  • Feasibility: Participant Retention Rate [ Time Frame: 44 days ]
  • Feasibility: Mindfulness-Based Intervention Program Adherence [ Time Frame: 44 days ]
  • Acceptability: Mindfulness-Based Intervention Program Evaluation [ Time Frame: 44 days ]
  • Feasibility: Survey Response Rate [ Time Frame: 44 days ]

Central Contacts and Locations

Central contacts

Sonia Research Associate, PhD

604-875-2345sonia.franciosi@cw.bc.ca

Locations

BC Children's Hospital

Recruiting

Vancouver, British Columbia, Canada, V6H 3V4

More Information

Sponsor

University of British Columbia

Last update posted

May 8, 2024

Last verified

May, 2024

Keywords

  • Pediatrics
  • Idiopathic
  • Chest Pain

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-25. This information was provided to ClinicalTrials.gov by University of British Columbia on 2024-05-08. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.